Deferasirox DOC 180 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

DEFERASIROX 180 mg/stuk

Beschikbaar vanaf:

DOC Generici S.r.l. Via Filippo Turati 40 20121 MILANO (ITALIË)

INN (Algemene Internationale Benaming):

DEFERASIROX 180 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MAGNESIUMSTEARAAT (E 470b) ; POLOXAMEER 188 ; POLYETHYLEENGLYCOL (E 1521) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MAGNESIUMSTEARAAT (E 470b) ; POLOXAMEER 188 ; POLYETHYLEENGLYCOL (E 1521) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

_May 2020: NL MA approval – Oct 2021: EoP var IA/004 – Proposed
var 08 _
1
PACKAGE LEAFLET:
INFORMATION FOR
THE
U
SE
R
Deferasirox DOC 90 mg, filmomhulde tabletten
Deferasirox DOC 180 mg, filmomhulde tabletten
Deferasirox DOC 360 mg, filmomhulde tabletten
Deferasirox
READ ALL OF THIS LEAFLET C
A
R
EF
U
LLY
B
EFO
R
E YOU
START
TAKING THIS MEDICINE BECAUSE IT CO
N
T
A
I
N
S
IMPORTANT
INFORMATION FOR YO
U
.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed only for you or your child. Do not
pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LE
A
FLE
T
1.
What Deferasirox DOC is and what it is used for
2.
What you need to know before you take
3.
How to take Deferasirox DOC
4.
Possible side effects
5.
How to store Deferasirox DOC
6.
Contents of the pack and other information
1.
WHAT
DEFERASIROX DOC
IS AND WHAT IT IS USED FO
R
WHAT
DEFERASIROX DOC
IS
Deferasirox DOC contains an active substance called deferasirox. It is
an iron chelator which is a medicine
used to remove the excess iron from the body (also called iron
overload). It traps and removes excess iron
which is then excreted mainly in the stools.
WHAT
DEFERASIROX DOC
IS USED FO
R
Repeated blood transfusions may be necessary in patients with various
types of anaemia (for example
thalassaemia,
sickle
cell
disease
or
myelodysplastic
syndromes
(MDS)).
However,
repeated
blood
transfusions can cause a build-up of excess iron. This is because
blood contains iron and your body does not
have a natural way to remove the excess iron you get with your blood
transfusions. In patients with non-
transfusion-dependent thalassaemia syndromes, iron overload may also
develop over time, mainly due to
increased absorption of dietary iron in response to

Productkenmerken

_May 2020: NL MA approval – Dec 2021: approval var.05 – Proposed
var. 08 _
1
1.
NAME OF THE
MEDICINAL
PRO
DU
CT
Deferasirox DOC 90 mg, filmomhulde tabletten
Deferasirox DOC 180 mg, filmomhulde tabletten
Deferasirox DOC 360 mg, filmomhulde tabletten
2.
QUALITATIVE
AND
QUANTITATIVE
CO
M
PO
S
I
T
I
O
N
Deferasirox DOC 90 mg film-coated tablets
Each film-coated tablet contains 90 mg deferasirox.
Deferasirox DOC 180 mg film-coated tablets
Each film-coated tablet contains 180 mg deferasirox.
Deferasirox DOC 360 mg film-coated tablets
Each film-coated tablet contains 360 mg deferasirox.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FOR
M
Film-coated tablet
Deferasirox DOC 90 mg film-coated tablets
Light blue, ovaloid, biconvex, film-coated tablets with bevelled
edges, embossed with ‘90’ on one side and
plain on the other side. The dimensions of the tablet are
approximately 10.3 mm x 4.1 mm.
Deferasirox DOC 180 mg film-coated tablets
Medium blue, ovaloid, biconvex, film-coated tablets with bevelled
edges, embossed with ‘180’ on one side
and plain on the other side. The dimensions of the tablet are
approximately 13.4 mm x 5.4 mm.
Deferasirox DOC 360 mg film-coated tablets
Dark blue, ovaloid, biconvex, film-coated tablets with bevelled edges,
embossed with ‘360’ on one side and
plain on the other side. The dimensions of the tablet are
approximately 16.6 mm x 6.6 mm.
4.
CLINICAL
P
A
RT
I
C
U
L
A
R
S
4.1
THERAPEUTIC I
ND
IC
A
T
IO
N
S
Deferasirox DOC is indicated for the treatment of chronic iron
overload due to frequent blood transfusions
(≥7 ml/kg/month of packed red blood cells) in patients with beta
thalassaemia major aged 6 years and older.
Deferasirox DOC is also indicated for the treatment of chronic iron
overload due to blood transfusions when
deferoxamine therapy is contraindicated or inadequate in the following
patient groups:
-
in paediatric patients
with beta thalassaemia major with iron overload due to frequent blood
transfusions (≥7 ml/kg/month of packed red blood cells